EP1121117B1 - Conditionnement d'une preparation d'oxaliplatine - Google Patents
Conditionnement d'une preparation d'oxaliplatine Download PDFInfo
- Publication number
- EP1121117B1 EP1121117B1 EP99946400A EP99946400A EP1121117B1 EP 1121117 B1 EP1121117 B1 EP 1121117B1 EP 99946400 A EP99946400 A EP 99946400A EP 99946400 A EP99946400 A EP 99946400A EP 1121117 B1 EP1121117 B1 EP 1121117B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- oxaliplatinum
- flexible
- bag
- pharmaceutical preparation
- medical use
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/28—Compounds containing heavy metals
- A61K31/282—Platinum compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/243—Platinum; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Definitions
- the present invention relates to a pocket flexible waterproof for medical use containing a pharmaceutical preparation oxaliplatin.
- This pharmaceutical preparation has been stored in vials in neutral glass for pharmaceutical use under a gas atmosphere inert.
- bottles if they are suitable for the long-term storage of the pharmaceutical preparation, are not to contain this preparation during administration by infusion.
- PVC polyvinyl chloride
- the purpose of the present invention is to provide Oxaliplatin pharmaceutical liquid preparations which can be not only kept over a long period of time without no loss of quality can be noted, but also which can be used in particular for infusion operations without that no transfer operation for liquid preparations pharmaceutical is only to be performed by nursing staff
- the present invention relates to a flexible pocket waterproof for medical use containing a pharmaceutical preparation oxaliplatin in liquid form as defined in claim 1.
- the different variants are such that defined in claims 2 to 9.
- the pharmaceutical preparation of oxaliplatin according to the present invention is stored, then used directly, in a flexible pocket and flexible made from plastic materials chosen from polyethylenes (PE), polypropylenes (PP), polyethyl acetates and vinyl, polyamides (PA), polyisobutyls (PIB). Latex can also be used.
- PE polyethylenes
- PP polypropylenes
- PA polyethyl acetates and vinyl
- PA polyamides
- PIB polyisobutyls
- the envelope of the pocket has preferably a multilayer structure. More preferably, the layer internal which is in direct contact with the pharmaceutical preparation consists of PP, the outer layer or any layers intermediates which may consist of any of the plastics previously mentioned. The outer layer or any layers intermediates can even be made of PVC, oxaliplatin does not not in direct contact with this material.
- the flexible pouch of the invention is preferably made up of a material made of 70% PP and 30% PA 11 and commonly called V90.
- This oxygen tightness property is very important considering the sensitivity of oxaliplatin to oxidizing products, the degradation products generated during such oxidation being general pharmacologically inactive and may even be toxic to the body. This quality is entirely appropriate when the use of flexible pouches which have the advantage, compared to the bottles in glass, not to require the presence of an inert gas atmosphere.
- the material V90 also offers the advantage from the point of view ecological to be recycled and to be used in another form, which is not not the case with PVC.
- the materials mentioned above, and in particular PP (V90), also have the advantage of better supporting high temperatures. This is particularly interesting during sterilization flexible bags containing an oxaliplatin solution by autoclave. This sterilization is much easier because by increasing the temperature we can thus reduce the exposure time.
- the liquid solution of oxaliplatin contained in these bags has preferably a concentration between 1 and 8 mg / ml.
- the concentration of oxaliplatin is between 1 and 5 mg / ml with a pH between 4 and 7, ideally between 4.5 and 6.
- the oxaliplatin content in the preparation according to a particular form of the invention contains at least 95% of the initial content and has a clear colorless appearance without precipitate after storage for a pharmaceutically acceptable period.
- liquid solution of oxaliplatin packaged in flexible pouch is stable for a period going on a period well beyond three months, and even beyond six months.
- this liquid solution of oxaliplatin packaged in a bag appears to remain stable for at least a year.
- Fig. 6 shows the change in pH over 12 weeks. This pH is between 4.7 and 5.9 and varies very little over time, which proves well that the oxaliplatin solution remains stable in this type of bag. This system has a stability similar to that observed for a solution of oxaliplatin subject to the same conditions and packaged in a vial of glass as shown in Fig. 7.
- Oxaliplatin pharmaceutical preparations can be stored, without any chemical degradation of oxaliplatin being observed, over a long period in flexible pockets, from the moment it is not in direct contact with a PVC-based material.
- Oxaliplatin pharmaceutical preparations due to the flexibility of the materials constituting the pockets, are found to be ready for use in transfusion without any transfer operation being necessary.
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CH206798 | 1998-10-14 | ||
CH206798 | 1998-10-14 | ||
PCT/IB1999/001670 WO2000021527A2 (fr) | 1998-10-14 | 1999-10-13 | Conditionnement d'une preparation d'oxaliplatine |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1121117A2 EP1121117A2 (fr) | 2001-08-08 |
EP1121117B1 true EP1121117B1 (fr) | 2002-06-05 |
Family
ID=4225128
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP99946400A Expired - Lifetime EP1121117B1 (fr) | 1998-10-14 | 1999-10-13 | Conditionnement d'une preparation d'oxaliplatine |
Country Status (14)
Country | Link |
---|---|
US (1) | US6866857B1 (es) |
EP (1) | EP1121117B1 (es) |
JP (1) | JP4884587B2 (es) |
AT (1) | ATE218337T1 (es) |
AU (1) | AU762138B2 (es) |
BR (1) | BRPI9914508B8 (es) |
CA (1) | CA2346564C (es) |
DE (1) | DE69901725T2 (es) |
DK (1) | DK1121117T3 (es) |
ES (1) | ES2178474T3 (es) |
HK (1) | HK1039280B (es) |
MX (1) | MXPA01003799A (es) |
PT (1) | PT1121117E (es) |
WO (1) | WO2000021527A2 (es) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2006072440A1 (de) * | 2004-12-29 | 2006-07-13 | Hexal Ag | Kunststoff-flasche für oxaliplatinlösung |
US7829113B2 (en) | 2005-03-10 | 2010-11-09 | Mebiopharm Co., Ltd. | Liposome compositions |
US7888523B2 (en) | 2004-09-01 | 2011-02-15 | Platco Technologies (Proprietary) Limited | Preparation of platinum(II) complexes |
US7888390B2 (en) | 2003-11-25 | 2011-02-15 | Platco Technologies (Proprietary) Limited | Preparation of platinum(II) complexes |
US7956208B2 (en) | 2006-01-30 | 2011-06-07 | Platco Technologies (Proprietary) Limited | Preparation of platinum (II) complexes |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2002047725A2 (fr) * | 2000-12-12 | 2002-06-20 | Debiopharm S.A. | Preparation pharmaceutique d'oxaliplatine pour administration par voie parenterale et procede d'obtention de ladite preparation |
ES2287238T3 (es) | 2001-03-02 | 2007-12-16 | Debiopharm S.A. | Utilizacion de un vial que contiene una solucion de oxaliplatino. |
EP1404689A1 (en) * | 2001-07-02 | 2004-04-07 | Debiopharm S.A. | Oxaliplatin active substance with a very low content of oxalic acid |
US6476068B1 (en) | 2001-12-06 | 2002-11-05 | Pharmacia Italia, S.P.A. | Platinum derivative pharmaceutical formulations |
DE102004063347A1 (de) * | 2004-12-23 | 2006-07-13 | Stada Arzneimittel Ag | Gebrauchsfertige Gemcitabinlösungen und Gemcitabinlösungskonzentrate |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6041077B2 (ja) | 1976-09-06 | 1985-09-13 | 喜徳 喜谷 | 1,2‐ジアミノシクロヘキサン異性体のシス白金(2)錯体 |
JPS60199456A (ja) * | 1984-03-26 | 1985-10-08 | 住友ベークライト株式会社 | 血液バツグ |
US5492534A (en) * | 1990-04-02 | 1996-02-20 | Pharmetrix Corporation | Controlled release portable pump |
JP3212679B2 (ja) * | 1992-03-31 | 2001-09-25 | 出光興産株式会社 | 医療用輸液バッグ |
CN1138541C (zh) * | 1994-08-08 | 2004-02-18 | 德彪药品股份有限公司 | 一种药学上稳定的奥沙利铂制剂 |
JPH08155007A (ja) * | 1994-12-02 | 1996-06-18 | Mitsui Petrochem Ind Ltd | 薬剤充填容器製剤及びこれに用いる容器 |
DE19542716A1 (de) * | 1995-11-16 | 1997-05-22 | Braun Melsungen Ag | Polymer-Composit-Schlauchfolie |
SE9601348D0 (sv) * | 1996-04-10 | 1996-04-10 | Pharmacia Ab | Improved containers for parenteral fluids |
ATE338553T1 (de) * | 1997-03-07 | 2006-09-15 | Sanofi Aventis Us Llc | Antitumorkombination aus 3-amino-1,2,4- benzotriazine 1,4-dioxid/paclitaxel/platin |
GB9804013D0 (en) | 1998-02-25 | 1998-04-22 | Sanofi Sa | Formulations |
-
1999
- 1999-10-13 CA CA2346564A patent/CA2346564C/fr not_active Expired - Lifetime
- 1999-10-13 MX MXPA01003799A patent/MXPA01003799A/es active IP Right Grant
- 1999-10-13 BR BRPI9914508A patent/BRPI9914508B8/pt not_active IP Right Cessation
- 1999-10-13 AU AU58807/99A patent/AU762138B2/en not_active Expired
- 1999-10-13 DE DE69901725T patent/DE69901725T2/de not_active Expired - Lifetime
- 1999-10-13 US US09/807,586 patent/US6866857B1/en not_active Expired - Lifetime
- 1999-10-13 WO PCT/IB1999/001670 patent/WO2000021527A2/fr active IP Right Grant
- 1999-10-13 JP JP2000575503A patent/JP4884587B2/ja not_active Expired - Lifetime
- 1999-10-13 EP EP99946400A patent/EP1121117B1/fr not_active Expired - Lifetime
- 1999-10-13 ES ES99946400T patent/ES2178474T3/es not_active Expired - Lifetime
- 1999-10-13 PT PT99946400T patent/PT1121117E/pt unknown
- 1999-10-13 DK DK99946400T patent/DK1121117T3/da active
- 1999-10-13 AT AT99946400T patent/ATE218337T1/de active
-
2002
- 2002-02-04 HK HK02100838.4A patent/HK1039280B/zh unknown
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7888390B2 (en) | 2003-11-25 | 2011-02-15 | Platco Technologies (Proprietary) Limited | Preparation of platinum(II) complexes |
US7888523B2 (en) | 2004-09-01 | 2011-02-15 | Platco Technologies (Proprietary) Limited | Preparation of platinum(II) complexes |
WO2006072440A1 (de) * | 2004-12-29 | 2006-07-13 | Hexal Ag | Kunststoff-flasche für oxaliplatinlösung |
US7829113B2 (en) | 2005-03-10 | 2010-11-09 | Mebiopharm Co., Ltd. | Liposome compositions |
US8758810B2 (en) | 2005-03-10 | 2014-06-24 | Mebiopharm Co., Ltd. | Liposome compositions |
US7956208B2 (en) | 2006-01-30 | 2011-06-07 | Platco Technologies (Proprietary) Limited | Preparation of platinum (II) complexes |
Also Published As
Publication number | Publication date |
---|---|
WO2000021527A3 (fr) | 2000-08-17 |
ATE218337T1 (de) | 2002-06-15 |
ES2178474T3 (es) | 2002-12-16 |
EP1121117A2 (fr) | 2001-08-08 |
US6866857B1 (en) | 2005-03-15 |
PT1121117E (pt) | 2002-10-31 |
BRPI9914508B8 (pt) | 2021-05-25 |
MXPA01003799A (es) | 2003-06-09 |
HK1039280B (zh) | 2003-02-14 |
WO2000021527A2 (fr) | 2000-04-20 |
BR9914508A (pt) | 2001-10-30 |
HK1039280A1 (en) | 2002-04-19 |
JP2002527390A (ja) | 2002-08-27 |
CA2346564A1 (fr) | 2000-04-20 |
DE69901725T2 (de) | 2003-01-30 |
BRPI9914508B1 (pt) | 2021-04-20 |
DE69901725D1 (de) | 2002-07-11 |
DK1121117T3 (da) | 2002-09-16 |
AU5880799A (en) | 2000-05-01 |
JP4884587B2 (ja) | 2012-02-29 |
CA2346564C (fr) | 2011-05-03 |
AU762138B2 (en) | 2003-06-19 |
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